A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

Inclusion Criteria:

* Be at least 12 years of age
* Have a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma
* Be ineligible for curative surgery for pheochromocytoma
* Have failed a prior therapy for pheochromocytoma/paraganglioma or are not candidates for chemotherapy or other curative therapies
* Be on stable antihypertensive medication for pheochromocytoma-related hypertension for at least 30 days
* Have at least one tumor site by CT or MR or iobenguane I 131 scan
* Have an expected survival of at least 6 months
* Subjects must agree to use an acceptable form of birth control (abstinence, IUD, oral contraception, barrier and spermicide or hormonal implant) during this study and for 6 months following Therapeutic Doses of Ultratrace Iobenguane I 131.
* Male subjects must agree not to father a child during the period beginning immediately after administration of the first Therapeutic Dose of Ultratrace Iobenguane I 131 during the study and ending six months after administration of the last Therapeutic Dose of Ultratrace Iobenguane I 131.

Exclusion Criteria:

Subjects will be excluded if any of the following conditions are observed:

* \<50% of FDG (if data are available) positive lesions are MIBG avid
* Pregnant or nursing females
* Active CNS lesions by CT/MR scanning within 3 months of study entry
* New York Heart Association class IV heart failure, symptomatic congestive heart failure \[New York Heart Association class IV with another medical disorder\], unstable angina pectoris, cardiac arrhythmia
* Received any previous systemic radiotherapy resulting in marrow toxicity within 3 months of study entry or have active malignancy (other than pheochromocytoma/paraganglioma) requiring additional treatment during the active phase or follow up period of the Ultratrace® iobenguane I 131 trial.
* Administered prior whole-body radiation therapy
* Received external beam radiotherapy to \> 25% of bone marrow
* Administered prior chemotherapy within 30 days or have active malignancy (other than pheochromocytoma/ paraganglioma) requiring additional treatment during the active phase or follow up period of the Ultratrace iobenguane I 131 trial.
* Karnofsky Performance Status is \< 60
* Platelets \< 80,000/μL
* Absolute neutrophil count (ANC) \< 1,200/μL, Total bilirubin \> 1.5 times the upper limit of normal, AST/SGOT or ALT/SGPT \> 2.5 times the upper limit of normal
* Diagnosed with AIDS or HIV-positive
* Active chronic alcohol abuse, chronic liver disease or hepatitis
* Renal dysfunction/impairment
* Known allergy to iobenguane that has required medical intervention
* Received a therapeutic investigational compound and/or medical device/prior chemotherapy within 30 days before admission into this study
* Receiving a medication which inhibits tumor uptake of iobenguane I 131
* Any medical condition or other circumstances (i.e., uncontrolled current illness including but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with the study requirements.
* Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study